FDA Medical Device Recalls (openFDA)
Cook, Inc.: COOK Stiffened Micropuncture Introducer Set, 4 FR. Product Reorder Number: MPIS-401-10.0-SC-NT
- Recall number
- Z-0426-03
- Recalling firm
- Cook, Inc.
- Product
- COOK Stiffened Micropuncture Introducer Set, 4 FR. Product Reorder Number: MPIS-401-10.0-SC-NT
- Status
- Terminated
- Initiated
- 2002-11-25
- Posted
- 2003-02-28
- Terminated
- 2003-03-21
- Reason
- The tip of the stiffened cannula might break during use and remain in the patient.
- Root cause
- Other
- Action
- Recall letters were sent to each customer on November 26, 2002 advising them of the recall and to return stocks on hand.
- Quantity
- 4,223
- Distribution
- United States, Brazil, Canada, Dominican Republic and Israel.
- Lot, serial or model codes
- All lots on the market as of 11/25/2002.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DYB
- Firm FEI
- 1820334
- Firm city
- Bloomington
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28